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Sign in to claim this brandXIAMEN BOSON BIOTECH CO., LTD.
China·CN-MF-000001096
Last updated September 17, 2026
Information
- Country
- China
- Address
- No. 90-94, Tianfeng Road, Xiamen, China
- Website
- www.bosonbio.com
- —
- —
- [email protected]
- Phone
- +86-592-3965101
- PRRC Contact
- Haolong Shen
- EUDAMED SRN
- CN-MF-000001096
- FDA FEI Number
- 3008825965
- DUNS Number
- —
Catalogue (287)
Page 3 of 6| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Rapid Urine Alcohol Test Card | 1L29C3 | EUDAMED | IVD General | Active |
| Rapid Influenza A Antigen Test Card | 1N17C5 | EUDAMED | IVD General | Active |
| Rapid SARS-CoV-2 Antigen Test Card | 1N40C5-2 | EUDAMED | IVD devices for self-testing | Active |
| PIC assay (CLIA) | 7M36V1-B-EU, 7M36U1-B-EU, 7M36P1-B-EU | EUDAMED | IVD General | Active |
| Anti-Streptolysin O Test (FIA) | 5M28C2-25-EU, 5M28C2-50-EU | EUDAMED | IVD General | Active |
| Rapid Anti-CCP Antibody Test | 1M26C2-1-EU, 1M26C2-25-EU | EUDAMED | IVD General | Active |
| Rapid SARS-CoV-2/Flu A+B/RSV Antigen Test Card | 1N45C5-1 | EUDAMED | IVD General | Active |
| Rapid Myoglobin Test Card | 1J03C2 | EUDAMED | IVD General | Active |
| Hypersensitive Troponin I assay (CLIA) | 7J14V1-B-EU, 7J14U1-B-EU, 7J14P1-B-EU | EUDAMED | IVD General | Active |
| Follicle-Stimulating Hormone assay (CLIA) | 7D01V1-B-EU, 7D01U1-B-EU, 7D01P1-B-EU | EUDAMED | IVD General | Active |
| Procalcitonin Test (FIA) | 5M17C2-25-EU, 5M17C2-50-EU | EUDAMED | IVD General | Active |
| HbA1C Test (FIA) | 5M22C2-25-EU, 5M22C2-50-EU | EUDAMED | IVD General | Active |
| Rapid Carisoprodol Test | 1L69C3-1-EU, 1L69C3-25-EU,1L69S3-1-EU, 1L69S3-50-EU | EUDAMED | IVD General | Active |
| Free Triiodothyronine assay (CLIA) | 7B03V1-B-EU, 7B03U1-B-EU, 7B03P1-B-EU | EUDAMED | IVD General | Active |
| Rapid Mycoplasma Pneumoniae Antigen Test | 1O26C5-1-EU,1O26C5-20-EU | EUDAMED | IVD General | Active |
| Rapid Opiate-2000 Test Card | Rapid Opiate-2000 Test Card | EUDAMED | IVD General | Active |
| Rapid Dengue NS1 Antigen Test Card | 1N23C2 | EUDAMED | IVD General | Active |
| NT-proBNP assay (CLIA) | 7J07V1-B-EU, 7J07U1-B-EU, 7J07P1-B-EU | EUDAMED | IVD General | Active |
| Vitamin B12 assay (CLIA) | 7M09V1-B-EU, 7M09U1-B-EU, 7M09P1-B-EU | EUDAMED | IVD General | Active |
| Sample Extraction Buffer | 1A0317-E | EUDAMED | Class A | Active |
| Rapid UR-144 Test | 1L62C3-1-EU, 1L62C3-25-EU,1L62S3-1-EU, 1L62S3-50-EU | EUDAMED | IVD General | Active |
| Rapid DOA-11 Panel Test Cup | 1L33K3 | EUDAMED | IVD General | Active |
| Rapid α-PVP Test | 1L68C3-1-EU, 1L68C3-25-EU,1L68S3-1-EU, 1L68S3-50-EU | EUDAMED | IVD General | Active |
| Rapid Methamphetamine Test Strip | 1L10S3 | EUDAMED | IVD General | Active |
| Cocaine Saliva Test Card | 1L05C5 | EUDAMED | IVD General | Active |
| Cancer Antigen 125 assay (CLIA) | 7C03V1-B-EU, 7C03U1-B-EU, 7C03P1-B-EU | EUDAMED | IVD General | Active |
| Respiratory Syncytial Virus Antigen Test (FIA) | 5N26C5-20-EU, 5N26C5-40-EU | EUDAMED | IVD General | Active |
| SARS-CoV-2 Antigen Test (FIA) | 5N40C5-20-EU, 5N40C5-40-EU | EUDAMED | IVD General | Active |
| Hypersensitive Troponin T assay (CLIA) | 7J15V1-B-EU, 7J15U1-B-EU, 7J15P1-B-EU | EUDAMED | IVD General | Active |
| Chemiluminescence Immunoassay Analyzer | BOSON 3000 | EUDAMED | Class A | Active |
| Rapid HEV IgG/IgM Combo Test Card | 1H26C2 | EUDAMED | IVD General | Active |
| Rapid Methcathinone Test | 1L73C3-1-EU, 1L73C3-25-EU,1L73S3-1-EU, 1L73S3-50-EU | EUDAMED | IVD General | Active |
| Rapid MDMA Test Card | 1L08C3 | EUDAMED | IVD General | Active |
| Rapid Clonazepam Test Strip | 1L45S3 | EUDAMED | IVD General | Active |
| Rapid Fentanyl Test Card | 1L35C3 | EUDAMED | IVD General | Active |
| Rapid Strep A Test Card | 1O08C5 | EUDAMED | IVD General | Active |
| Procalcitonin Quantitative Test | 5M17C2 | EUDAMED | IVD General | Active |
| Rapid V. Cholerae O1 Test Strip | 1O15S4 | EUDAMED | IVD General | Active |
| Total Thyroxine assay (CLIA) | 7B05V1-B-EU, 7B05U1-B-EU, 7B05P1-B-EU | EUDAMED | IVD General | Active |
| Rapid Ketamine Test Strip | 1L07S3 | EUDAMED | IVD General | Active |
| Testosterone assay (CLIA) | 7E02V1-B-EU, 7E02U1-B-EU, 7E02P1-B-EU | EUDAMED | IVD General | Active |
| Rapid MDMA Test Strip | 1L08S3 | EUDAMED | IVD General | Active |
| Free Thyroxine assay (CLIA) | 7B02V1-B-EU, 7B02U1-B-EU, 7B02P1-B-EU | EUDAMED | IVD General | Active |
| Rapid Methadone Test Strip | 1L09S3 | EUDAMED | IVD General | Active |
| Total Triiodothyronine assay (CLIA) | 7B04V1-B-EU, 7B04U1-B-EU, 7B04P1-B-EU | EUDAMED | IVD General | Active |
| Gastrin-17 assay (CLIA) | 7C18V1-B-EU, 7C18U1-B-EU, 7C18P1-B-EU | EUDAMED | IVD General | Active |
| Rapid Saliva Alcohol Test Strip | 1L29S5 | EUDAMED | IVD General | Active |
| Thrombin-Antithrombin III Complex assay (CLIA) | 7M37V1-B-EU, 7M37U1-B-EU, 7M37P1-B-EU | EUDAMED | IVD General | Active |
| Rapid Leptospira IgG/IgM Combo Test | 1O23C2-1-EU, 1O23C2-25-EU | EUDAMED | IVD General | Active |
| Rapid Adenovirus Antigen Test Card | 1N06C4 | EUDAMED | IVD General | Active |
Related Companies
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Xiamen Boson Biotech Co., Ltd. US